High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

Summary

The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system. The participant's own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

Granulocyte-colony stimulating factor (G-CSF) and prednisone

Growth factor regimen; occurs at study entry

DRUG

Carmustine, etoposide, cytarabine, and melphalan (BEAM)

High-dose chemotherapy; occurs seven or more days following collection of autologous graft

PROCEDURE

Autologous hematopoietic stem cell transplant

Occurs after growth factor regimen and collection of autologous graft

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Richard A. Nash, MD · Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Presbyterian/St. Luke's Medical Center, Denver

• James D. Bowen, MD · Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, Washington

• George H. Kraft, MD · Departments of Neurology and Rehabilitation Medicine, University of Washington

• George J. Hutton, MD · The Maxine Messinger Multiple Sclerosis Clinic, The Methodist Hospital, Baylor College of Medicine

• Uday Popat, MD · Department of Blood and Marrow Transplantation, University of Texas, M.D. Anderson Cancer Center

• Michael K. Racke, MD · Department of Neurology, Ohio State University Medical Center

• Steven M. Devine, MD · Department of Hematology and Oncology, Ohio State University Medical Center

• Annette Wundes, MD · Department of Neurology, University of Washington

• George E. Georges, MD · Fred Hutchinson Cancer Research Center, Clinical Research Division, University of Washington

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• United States

Study Locations